Research Protections Policies

RP10 Dual Use Research of Concern (DURC)

Policy Status: 

Active

Policy Steward: 

Associate Vice President for Research, Director of the Office for Research Protections

Contents:

  • Purpose
  • Policy
  • Applicability
  • Definitions
  • Responsibilities
  • Submission Procedure
  • Further Information
  • References
  • PURPOSE:

    This policy outlines the mechanism used by The Pennsylvania State University to evaluate research that is potentially Dual Use Research of Concern (DURC). It establishes a system of oversight for DURC and the mitigation of risks where appropriate. The fundamental aim of this oversight is to preserve the benefits of life sciences research while minimizing the risk of misuse of the knowledge, information, products, or technologies provided by such research.

    This policy implements the provisions set forth in the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (“USG DURC Policy”) (see “References” below). The Office for Research Protections (ORP) at University Park has established an Institutional Review Entity (IRE) to review all potential DURC at University Park and all University campuses and colleges, except for the College of Medicine / Milton S. Hershey Medical Center (COM), which has established a separate IRE to review potential DURC at the COM.

    POLICY:

    Per the USG DURC Policy, life sciences research that directly involves non-attenuated forms of one or more of the following fifteen agents or toxins and falls into one of the seven listed experimental categories noted below must be evaluated by the University for DURC potential. Principal investigators (PI) are ultimately responsible for ensuring that all research involving any one of the fifteen agents or toxins listed below is submitted to the IRE for review.

    Agents and Toxins1

    1. Avian influenza virus (highly pathogenic)
    2. Bacillus anthracis
    3. Botulinum neurotoxin2
    4. Burkholderia mallei
    5. Burkholderia pseudomallei
    6. Ebola virus
    7. Foot-and-mouth disease virus
    8. Francisella tularensis
    9. Marburg virus
    10. Reconstructed 1918 influenza virus
    11. Rinderpest virus
    12. Toxin-producing strains of Clostridium botulinum
    13. Variola major virus
    14. Variola minor virus
    15. Yersinia pestis

    1Does not include attenuated strains of the agents and inactive forms of botulinum neurotoxin that are excluded from the Select Agent List.

    2For the purposes of this Policy, there are no exempt quantities of botulinum neurotoxin. Research involving any quantity of botulinum neurotoxin will be evaluated for DURC potential.

    Experimental Categories

    1. Enhances the harmful consequences of the agent or toxin
    2. Disrupts immunity or the effectiveness of an immunization against the agent or toxin without clinical and/or agricultural justification
    3. Confers to the agent or toxin resistance to clinically and/or agriculturally useful prophylactic or therapeutic interventions against that agent or toxin or facilitates their ability to evade detection methodologies
    4. Increases the stability, transmissibility, or the ability to disseminate the agent or toxin
    5. Alters the host range or tropism of the agent or toxin
    6. Enhances the susceptibility of a host population to the agent or toxin
    7. Generates or reconstitutes an eradicated or extinct agent or toxin listed above

    The ORP is responsible for coordinating DURC reviews and approvals for all University campuses and colleges except for the COM. The Office of Vice-Dean for Research is responsible for coordinating DURC reviews and approvals at the COM.

    APPLICABILITY:

    This policy is applicable to all life sciences research, testing or teaching activities with DURC potential conducted under the auspices of the University and applies to all University campus locations, including the COM.

    DEFINITIONS:

    1. Dual Use Research of Concern (DURC): Life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.
    2. Institutional Review Entity (IRE): The IRE is an oversight committee established by the University to review life sciences research using one or more of the fifteen select agents and toxins listed above for dual use potential, as well as work with researchers to assess the risks and benefits of the DURC and to develop risk mitigation plans when appropriate. The IRE provides ongoing oversight for any life sciences research identified as DURC and on-going compliance with any risk mitigation measures put into place. The IRE shall review risk mitigation plans annually and modify the plans as necessary.
    3. Institutional Contact for Dual Use Research of Concern (ICDURC): An individual designated by the University to serve as an institutional point of contact for questions regarding compliance with the implementation of the requirements for the oversight of DURC as well as the liaison between the institution and relevant federal funding agencies. The ICDURC also provides required reports to the relevant federal funding agencies. At University Park and all other campus locations except COM, the ICDURC is the Director, Institutional Biosafety Program, in the Office for Research Protections. The ICDURC at the COM is the Biological Safety Officer.
    4. Life sciences: Pertain to living organisms (e.g., microbes, human beings, animals, and plants) and their products, including all disciplines and methodologies of biology such as aerobiology, agricultural science, plant science, animal science, bioinformatics, genomics, proteomics, synthetic biology, environmental science, public health, modeling, engineering of living systems, and all applications of the biological sciences. The term is meant to encompass the diverse approaches for understanding life at the level of ecosystems, organisms, organs, tissues, cells, and molecules.
    5. Principal Investigator (PI): An individual who is designated by the University to manage a research program and who is responsible for the scientific and technical direction of that research.

    RESPONSIBILITIES:

    1. The PI must notify (see “Submission Procedure” below) the IRE as soon as:
      1. His/her research directly involves one or more of the fifteen agents and toxins listed above; or
      2. He/she anticipates that his/her research with one or more of the fifteen agents and toxins listed will also produce, aim to produce, or can be reasonably anticipated to produce one or more of the seven experimental effects listed above; or
      3. He/she concludes that his/her research with one or more of the fifteen agents and toxins listed above that also produces, aims to produce, or can be reasonably anticipated to produce one or more of the seven experimental effects listed above may meet the definition of DURC and should be considered or reconsidered by the IRE for its DURC potential.
    2. The PI must also:
      1. Work with the IRE to assess the dual use risks and benefits of the DURC and develop risk mitigation measures, if appropriate;
      2. Conduct DURC in accordance with the approved risk mitigation plan. This includes the responsibility to not conduct research that has been determined to be DURC until a risk mitigation plan has been approved (as outlined below);
      3. Be knowledgeable about and comply with all institutional and USG policies and requirements for oversight of DURC;
      4. Continue to assess his/her research to determine if, at any time, the research becomes subject to this Policy;
      5. Ensure that all laboratory personnel conducting life sciences research with one or more of the above listed agents or toxins have received the University’s identified education and training regarding DURC; and
      6. Communicate DURC in a responsible manner throughout the research process and not only at the time of publication. All communication shall be in compliance with the risk mitigation plan.
    3. The IRE will:
      1. Establish and implement internal policies and practices that ensure the identification and oversight of DURC; and
      2. Initiate the institutional review and oversight process when research is identified by a PI as utilizing one of the fifteen agents or toxins listed above. The institutional review and oversight process will include:
        1. Verification that one or more of the fifteen agents or toxins listed above is being utilized; and
        2. Review of the PI’s assessment of whether the research produces, aims to produce, or is reasonably anticipated to produce one or more of the seven experimental categories listed above; and
        3. A determination of whether or not the research meets the DURC definition, if the research involves one of the fifteen agents or toxins listed above and aims to produce, or is reasonably anticipated to produce one or more of the seven experimental categories listed above.
        4. For research determined to be DURC, the IRE will:
          1. Assess the potential benefits of the DURC;
          2. Consider the risks and benefits of the DURC; and
          3. Develop a draft risk mitigation plan for conducting the DURC and for communicating its findings; and
          4. Work with the PI and the appropriate federal agency to develop a final risk mitigation plan. The risk mitigation plan will be reviewed by the IRE at least annually.
    4. The University will:
      1. Ensure that internal policies establish a mechanism for the PI to immediately refer a project to the IRE as soon as research uses one or more of the fifteen agents and toxins listed above that also produces, aims to produce, or can be reasonably anticipated to produce one or more of the seven experimental effects listed above;
      2. Maintain an IRE which is composed of at least five members, empowered by the University to make decisions about DURC, is sufficiently knowledgeable about biosafety and biosecurity issues, has a range of life sciences expertise, and has at least one member who is familiar with the University’s procedures and policies;
      3. Within 30 calendar days of the IRE’s determination of whether or not the research meets the definition of DURC, provide notification to the applicable funding agency of any research that involves one or more of the fifteen agents and toxins and one or more of the seven experimental effects listed above. Said notification shall also include the IRE’s determination of whether the research meets or does not meet the definition of DURC. Note: For non-federally funded research, all required notifications will be made to the National Institutes of Health (“NIH”);
      4. Within 90 calendar days of the IRE’s determination that the research meets the definition of DURC, provide a copy of the draft risk mitigation plan developed by the IRE and PI to the applicable funding agency for its review;
      5. Within 30 calendar days of any change in status of a DURC project (including when the research is determined by the IRE to no longer meet the definition of DURC) or any proposed change to the risk mitigation plan, provide notification of the change to the applicable funding agency;
      6. Provide education and training on DURC for individuals conducting life sciences research involving one or more of the fifteen agents and toxins listed above. Records of education and training will be maintained by the ORP for the term of the research grant or contract plus three years after its completion;
      7. Maintain records of the IRE reviews and determinations and any risk mitigation plans for the term of the applicable research grant or contract plus three years after its completion (but no less than a total of eight years); and
      8. Report instances of noncompliance with the USG DURC Policy, as well as instances of noncompliance with any mitigation measures undertaken by the University in order to prevent reoccurrence of similar noncompliance, within 30 calendar days to the applicable funding agency.

    SUBMISSION PROCEDURE:

    Submission forms for all University campuses and colleges, except for the COM, can be obtained from the ORP website. Completed forms should be returned to the ORP, as detailed on the DURC submission form. Copies of submissions received by ORP will be circulated to IRE members.

    Submission forms for the COM can be obtained from the COM IBC website. Completed forms should be returned to the Biosafety Committee Office, Room C1630A, Mail Code H138. 500 University Drive, Hershey, PA. Copies of submissions will be circulated to IRE committee members.

    Appeals will be heard by the IRE; however, by federal policy, the IRE has final authority and DURC determinations cannot be overruled by any administrator at the University.

    FURTHER INFORMATION:

    In addition, any activities associated with the agents and toxins identified in this policy must also comply with Federal Export Control Regulations. Consequently, the DURC review would also need to be supplemented with an export compliance review if the research involved any potential export controlled activities, such as foreign sponsorship, foreign collaborations and/or international travel. More information about Penn State Export Compliance policies and procedures is available at export.psu.edu.

    For questions, additional detail, or to request changes to this policy, please contact the Office of the Associate Vice President for Research, Director of the Office for Research Protections.

    REFERENCES:

    1. United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern 
    2. March 2012 DURC Policy 
    3. A Companion Guide to the US Government Policies for Oversight of Life Sciences Dual Use Research of Concern (DURC) 
    4. Dual Use Research of Concern, Public Health Emergency 
    5. Case Study 
    6. Select Agent Regulations 
    7. Penn State University Policy RA40, Compliance with Federal Export Regulations for Sponsored Research Efforts, and Policy AD89, University Export Compliance Policy

    Effective Date: April 17, 2017
    Date Approved: April 13, 2017
    Date Published: April 17, 2017 (Editorial changes, June 27, 2017)

    Most recent changes:

    June 27, 2017 - Editorial changes to the footnotes in the POLICY section (Agents and Toxins).

    Revision History (and effective dates):

    April 17, 2017 - New Policy.